健康促进者和器官捐赠 (PdD)
2020年4月29日 更新者:Temple University
Promotoras de Donación:利用社区卫生工作者增加老年西班牙裔的捐赠者登记
年龄较大的西班牙裔(50 岁以上)在移植候补名单上的比例过高,但作为已故捐赠者和移植接受者的比例却偏低。
此应用程序提出了形成性研究,以设计和实证测试电子学习模块 Promotoras de Donación,以培训已经为其社区提供文化和语言敏感服务的社区卫生工作者(即 Promotoras),与老年人讨论和促进器官捐赠美国 3 个地理上不同的社区中的西班牙裔妇女。拟议的干预措施利用既定且基于证据的 Promotoras 计划来提高美国西班牙裔社区内的捐助者指定率,并减少该人群在获得移植方面的差异。
研究概览
详细说明
尽管对器官捐赠持积极态度,但美国注册器官捐赠者数量的增加继续对专业和研究团体提出挑战。
鉴于需要根据血型和人类白细胞抗原将捐赠器官与接受者相匹配,提高少数民族的捐赠者指定率尤为重要——当捐赠者和接受者具有相同的种族背景时,才能找到最佳匹配。
在西班牙裔社区,外行健康教育者(即 Promotoras)接受培训,以促进赋予选民权力和使他们能够预防疾病的行为,并加强对他们健康的控制和改善。
与代表西班牙裔人口最大亚群的美国不同地区(宾夕法尼亚州、伊利诺伊州、德克萨斯州)的四个 Promotoras 组织的领导层合作,这项试点研究建议利用现有的非专业健康教育者网络来倡导器官捐赠和在 50 岁以上的西班牙裔女性中促进捐赠者登记(第一人称同意)。
具体而言,本研究将收集为 Promotoras 设计教育和行为交流电子学习模块所需的形成性数据,并测试培训对 Promotoras 器官捐赠知识、讨论和促进捐赠者注册的信心以及捐赠者注册效率提高率的影响在成熟和年长的西班牙裔女性中。
对西班牙裔妇女和 Promotoras 的焦点小组访谈将确定这两个群体对器官捐赠登记的信息需求和关注点;与外行教育工作者的访谈还将衡量交互偏好以及由此产生的基于网络的培训的内容和设计问题(目标 1)。
这些数据将用于开发电子学习模块,以教育 Promotoras 有关器官捐赠的知识,并培训他们讨论捐赠和促进捐赠者登记(目标 2)。
一项简短的定量调查将评估该模块对器官捐赠知识和信心(沟通自我效能)的影响,讨论捐赠和促进捐赠者指定。
我们将评估 Promotoras 促进器官捐赠的功效,方法是评估注册为死后器官捐赠者的 50 岁及以上西班牙裔女性人数占参加由受过培训的 Promotoras 领导的小组会议的所有女性的比例(目标 3)。
如果有效,电子学习模块可以很容易地在全国范围内传播,以培训 Promotoras 讨论和促进器官捐赠。
最终,这项“培训师培训”研究有可能提高美国西班牙裔社区的捐献者登记率,并有助于减少该人群在获得移植方面的差异。
研究类型
介入性
注册 (实际的)
621
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19122
- Temple University
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、OLDER_ADULT)
接受健康志愿者
是的
有资格学习的性别
全部
描述
纳入标准:
- 外行健康教育者 (Promotora):外行健康教育者必须年满 18 岁,已完成所有必要的 Promotoras 培训,并在招聘后 3 个月内积极与当地西班牙裔社区合作。
- 成熟的拉丁裔:符合条件的女性必须年满 50 岁,并且没有明显的认知障碍。
排除标准:
- 外行健康教育者 (Promotora):未经培训的外行健康教育者或目前在各自组织接受培训的人员将被视为不符合资格,在招募/注册时未作为 Promotora 积极工作的个人也是如此。
- 成熟拉丁裔:50 岁以下的西班牙裔女性,或有明显认知障碍的女性将被视为不符合资格。
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:北美
- 介入模型:单组
- 屏蔽:没有任何
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:单臂
Promotoras de Donación 电子学习模块将启动,40 名参与的非专业健康教育者将接受培训。
将通过公告电子邮件中嵌入的网站链接提供对该模块的访问。
为了评估 Promotoras de Donación 电子学习模块对非专业健康教育者的器官捐献知识和西班牙裔捐献者需求的影响,以及对捐赠和促进捐献者登记行为的信心交流,参与的非专业健康教育者将完成一项简短的在线调查注册后(预)和完成模块后(后)。
然后,训练有素的外行健康教育者将与成熟的拉丁裔举行至少 2 场小组会议(每场 6-8 人);总共有 80 场会议预计将有 480 至 640 名成熟的拉丁裔。
参与的成熟拉丁裔将在每次会议前后完成匿名纸笔调查,以评估对器官捐赠和捐赠者登记的态度变化以及登记为死后器官捐赠者的意图。
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Promotoras de Donación 是一种高度参与和互动的在线学习体验,它通过结合各种教学方法来适应多种学习风格。
该模块由两个部分组成:教学部分和基于技能的交流部分。
教学部分提供了有关器官捐赠和移植的基本信息以及西班牙裔社区对捐赠者的需求,并解决了老年拉丁裔普遍持有的对捐赠的担忧。
基于技能的部分提供有关有效地让小组参与讨论器官捐赠所需的关键沟通技巧的指导。
该部分旨在建立沟通的自我效能或信心,开启关于捐赠的讨论,解决参加小组会议的成熟和年长女性提出的担忧,并使用有说服力但非强制性的语言促进捐赠者登记的行为。
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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捐赠者登记
大体时间:3个月
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参加训练有素的非专业健康教育者主导的小组会议的成熟拉丁裔比例,他们也表示有意成为死后的器官、组织和眼睛捐献者
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3个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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沟通自我效能
大体时间:3个月
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非专业健康教育者将被要求对他们管理 10 种与讨论器官捐赠和促进捐赠者登记相关的沟通技巧的信心水平进行评分,数值范围从 0(完全没有信心)到 100(完全有信心)。
通过对每个项目的评分求和,将获得全局自我效能得分。
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3个月
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器官捐献知识
大体时间:3个月
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一系列 10 个真/假问题先前开发并用于评估西班牙裔美国人社区样本中的器官捐赠知识。
将创建一个全局知识分数,作为所有正确回答问题的总和,范围从 0 到 10。
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3个月
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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捐赠意向
大体时间:3个月
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一个 4 点李克特类型的项目将同意以下陈述:我计划在下个月注册为器官捐献者(1-强烈反对/4-强烈同意)。
分别表示同意和不同意的两个类别将被折叠以创建一个二分变量,指示注册意图(1-是/0-否)。
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3个月
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支持器官捐献
大体时间:3个月
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我们将使用单个 5 分李克特类型项目来获取参与者对器官捐赠的普遍支持。
该问题将要求受访者表明他们支持器官捐献的程度(1-完全不支持/5-完全支持)。
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3个月
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对 Promotoras de Donación 电子学习模块的看法
大体时间:3个月
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一系列 10 个 4 点李克特式问题将确定对基于 Web 的电子学习模块的看法,包括组织、长度、现实主义和对所涵盖材料的兴趣。
单个 5 分李克特式项目将获取受访者对模块整体质量的评分(1-差/5-优)。最后,两个开放式问题将要求受访者指出他们最喜欢和最不喜欢模块的方面。
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3个月
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Heather M Gardiner (Traino), PhD, MPH、Temple University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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有用的网址
- Organ Procurement and Transplantation Network. U.S. Department of Health & Human Services.
- Revised Uniform Anatomical Gift Act (2006). Last Revised or Amended in 2009. National Conference of Commissioners of Uniform State Laws
- Donate Life America. 2015 Annual Update
- Health Resources & Services Administration. Materials for 50+ audiences
- U.S. Census Bureau. U.S. Census Bureau projections show a slower growing, older, more diverse nation a half century from now
- Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. 10 Leading Causes of Death by Age Group, United States - 2013
- U.S. Census Bureau. American Fact Finder
- U.S. Department of Health & Human Services, Office of Minority Health, Think Cultural Health. Promoting Healthy Choices and Community Changes: An E-learning Program for Promotores De Salud
- Health Resources & Services Administration. Donation and transplantation: How does it work?; 2013
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年9月1日
初级完成 (实际的)
2020年4月27日
研究完成 (实际的)
2020年4月27日
研究注册日期
首次提交
2019年6月11日
首先提交符合 QC 标准的
2019年7月2日
首次发布 (实际的)
2019年7月5日
研究记录更新
最后更新发布 (实际的)
2020年5月1日
上次提交的符合 QC 标准的更新
2020年4月29日
最后验证
2020年4月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
匿名数据将通过向首席研究员提出书面请求提供使用。
具体而言,将从非专业健康教育者和成熟的拉丁裔收集的焦点小组和调查数据将以确保参与者隐私和机密性的方式共享。
数据中的任何识别信息都将在共享之前进行编辑。
为了进一步保护参与者免受演绎识别,请求数据的各方将被要求同意仅将数据用于研究目的,避免以任何方式识别参与者,通过加密和/或电子方式保护数据密码保护,并在分析完成后返回或销毁数据。
IPD 共享时间框架
本研究的数据将在研究的主要发现发表后提供
IPD 共享访问标准
向首席研究员 (Heather Gardiner) 提出的书面请求。
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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